MedPath

A pilot randomized controlled trial investigating the feasibility, acceptability and preliminary (cost-)effectiveness and implementation of a combined lifestyle intervention for outpatients with a severe or chronic psychiatric illness (CHAPTER)

Conditions
Mental disorder
psychiatric disorder
10037176
10024450
Registration Number
NL-OMON53239
Lead Sponsor
entis (Groningen)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

- Treated in an outpatient clinic of Lentis;
- Treated in specialist mental health care;
- Adult (18+);
- Capable to read, write and speak in the Dutch language;
- Available and capable to attend the intervention at set moments and
locations;
- Capable to follow the research procedures.

Exclusion Criteria

- Main diagnosis of eating disorder or obsessive-compulsive disorder;
- In current crisis, severe symptoms, suicidality, self-mutilation or distorted
reality;
- Receiving guidance for at least three times in one or more lifestyle domains
on a frequent basis (at least once every other week) in the past year;
- Other implications for lifestyle interventions that cannot be overcome (e.g.
due to physical illness, use of certain medication such as clozapine or
intellectual disability);
- (Temporary) Hospitalization or living in a supported housing facility;
- Inability to comply with the study requirements as mentioned in the
participant information letter, judged by the research team;
- No informed consent is given.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary outcome is the feasiblity and acceptability of the intervention and<br /><br>study procedures</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secundary outcomes are<br /><br>-the preliminiary effects on recoveyr, health, and lifestyle variables,<br /><br>-the preliminary costeffectiveness of the intervention,-<br /><br>-the subjectively experienced effects of the intervention<br /><br>-the barriers and fascilitators for implementation of the intervention in daily<br /><br>practice<br /><br>-the goals of participants during the intervention</p><br>
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